Quality Manager- Clinical Trials

3 days ago

Melbourne, Australia KE Select Full time

**About the Company**
Our client provides a range of pathology testing services to global clinical research organisations (CRO’s) to support Phase I to Phase IV clinical trials. Their parent company is one of the largest pathology firms in Australia. They have state-of-the-art purpose-built laboratories in Victoria and Queensland. The scope of testing includes Haematology, Chemical Pathology, Microbiology, Serology, Histology and other speciality testing services.

**The Role**
The role will provide Quality & Risk Management to two Clinical Laboratories (Melbourne & Brisbane) as a dedicated Histology Laboratory (Sydney). This is a national role and you will be supported by a team of 6 other quality managers working across various other business units Australia wide. Supportive and inclusive team environment.

Your duties will include:
**Clinical Trials Laboratory**:

- Establish and implement processes for identifying and assessing quality risks in clinical trials protocols, sample processing, analysis and storage, data collection, administration and general trial conduct, ensuring adherence to GCP and GCLP standards.
- Conduct internal audits.
- Facilitate regulatory inspections and external audits and support the preparation of responses to inspection findings.
- Represent ACL Clinical Trials in sponsor external audits and provide guidance to clinical trials staff for regulatory audit response.
- Develop and maintain quality management systems for clinical trials, including SOPs, work instructions, and templates, with a specific focus on GCP and GCLP requirements.
- Provide training and support to staff on quality-related topics and procedures.

**Histology Laboratory**:

- Ensure the Histology laboratories meet relevant certification and accreditation standards, which may include but not be limited to ISO 15189, ISO 17025, and NPAAC requirements.
- Conduct internal audits.
- Facilitate regulatory inspections and external audits and support the preparation of responses to inspection findings.
- Monitor NATA accreditation outcomes and completion of actions within the required timeframes in conjunction with the laboratory managers.
- Develop and maintain quality management systems, including SOPs, work instructions, and templates, with a specific focus on ISO 15189, ISO 17025, and NPAAC requirements.

**About you**:
To be considered for this role your skills and attributes should include:

- Bachelor’ Degree in Medical Science of equivalent
- Experience in regulatory inspections and audit procedures related to GCP/GCLP, NATA, ISO 15189, ISO 17025 and NPAAC standards.
- Strong knowledge of clinical trial processes, protocols, and data management, with a specific focus on GCP and GCLP requirements.
- High level of interpersonal and communication skills
- Excellent organisational skills with an ability to work independently.

**This is a Hybrid role, with flexibility to work from home 2 to 3 days a week. You will be required to travel to QLD/NSW bi-monthly.**

For more information about this role, please contact

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